Critical IllnessCCINCT03851822
Prevalence and Predictors of CCI in Patients With Acute Respiratory Failure (CCI)
An observational study of Critical Illness, run by University of Modena and Reggio Emilia.
Trial summary
Chronic Critical Illness (CCI) is a condition associated to patients surviving an acute phase of disease and respiratory failure (ARF) although remaining dependent on mechanical ventilation (MV). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- How many people
- 127 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 1 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Observational cohort
Who may be able to join
- older than 18 years of age
- consecutively admitted to RICU due to acute respiratory failure (ARF) requiring mechanical ventilation.
Who cannot join
- refractory shock (death < 24h)
- patient goals of care not consistent with aggressive management
- end stage COPD requiring home oxygen long term therapy or home non invasive ventilation support
- presence of interstitial lung disease
- history of neuromuscular disease
- chest wall deformities
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- pregnancy
- chemotherapy or radiotherapy within the past 30 days
- evidence of neurologic injury on CT scan and GCS < 8
- tracheostomy.
About this study
Official title: Prevalence and Predictors of Chronic Critical Illness in Patients With Acute Respiratory Failure
Chronic Critical Illness (CCI) is a condition associated to patients surviving an acute phase of disease and respiratory failure (ARF) although remaining dependent on mechanical ventilation (MV). The prevalence and the underlying mechanisms of CCI have not been elucidated in this population.An observational prospective cohort study was undertaken at the Respiratory Intensive Care Unit (RICU) of the University Hospital of Modena (Italy) from January 2016 to January 2018. Patients mechanically ventilated with ARF in this unit were enrolled. Demographics, diagnosis, severity scores (APACHEII, SOFA, SAPSII) and clinical conditions (septic shock, infections, acute respiratory distress syndrome [ARDS]) were recorded on admission. Respiratory mechanics and inflammatory-metabolic blood parameters were recorded on admission and within the first seven days of stay. All these variables were tested as potential predictors of CCI through appropriate univariate and multivariate analysis.
- Conditions
- Critical Illness
- Medical subject headings
- Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of CCI among patients admitted to Respiratory Intensive Care Unit (RICU) for Acute Respiratory Failure
The presence of CCI was defined as the need to perform tracheostomy in ICU associated with prolonged MV (the need for ventilatory support for more than 21 consecutive days for at least 6 h per day
Measured: 60 days from RICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2019
- Study start1 Jan 2016
- Primary completion1 Feb 2019
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Modena and Reggio Emilia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandro Marchioni, University of Modena and Reggio Emilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03851822
- Sponsor's protocol ID
- UModenaReggio3
- Acronym
- CCI
- Status last verified
- Mar 2022
- First submitted
- 21 Feb 2019
- Last updated
- 23 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Predictors of Chronic Critical Illness in Patients With Acute Respiratory Failure
- ClinicalTrials.gov ID
- NCT03851822
- Acronym / sponsor ID
- CCI / UModenaReggio3
- Conditions
- Critical Illness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- University of Modena and Reggio EmiliaUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 22 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic Critical Illness (CCI) is a condition associated to patients surviving an acute phase of disease and respiratory failure (ARF) although remaining dependent on mechanical ventilation (MV). The prevalence and the underlying mechanisms of CCI have not been elucidated in this population.An observational prospective cohort study was undertaken at the Respiratory Intensive Care Unit (RICU) of the University Hospital of Modena (Italy) from January 2016 to January 2018. Patients mechanically ventilated with ARF in this unit were enrolled. Demographics, diagnosis, severity scores (APACHEII, SOFA, SAPSII) and clinical conditions (septic shock, infections, acute respiratory distress syndrome [ARDS]) were recorded on admission. Respiratory mechanics and inflammatory-metabolic blood parameters were recorded on admission and within the first seven days of stay. All these variables were tested as potential predictors of CCI through appropriate univariate and multivariate analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Observational cohort
Key inclusion criteria (2 listed)
- older than 18 years of age
- consecutively admitted to RICU due to acute respiratory failure (ARF) requiring mechanical ventilation.
Key exclusion criteria (10 listed)
- refractory shock (death < 24h)
- patient goals of care not consistent with aggressive management
- end stage COPD requiring home oxygen long term therapy or home non invasive ventilation support
- presence of interstitial lung disease
- history of neuromuscular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of CCI among patients admitted to Respiratory Intensive Care Unit (RICU) for Acute Respiratory Failure
Time frame: 60 days from RICU admission
The presence of CCI was defined as the need to perform tracheostomy in ICU associated with prolonged MV (the need for ventilatory support for more than 21 consecutive days for at least 6 h per day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness, run by University of Modena and Reggio Emilia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of CCI among patients admitted to Respiratory Intensive Care Unit (RICU) for Acute Respiratory Failure (time frame: 60 days from RICU admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2022.